The Informed Consent Process
Informed consent is central to the ethical conduct of research with human subjects. Informed consent should always be obtained from human participants when conducting research.
- Consent – Adults (18 years of age and older)
- Assent – Minors (under the age of 18)
- Parental/Guardian Consent – when working with minors
The templates to be used can be found on the Mentor App on the Fordham portal. It is important that consent forms are written in simplified language that the specific population being studied can understand.
Informed consent should contain the following elements:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; An explanation of whom to contact, together with phone numbers, for answers to pertinent questions about the research and research subjects' rights, and whom to contain in the event of a research-related injury to the subject. (The investigator should be the contact for questions about the research and the University Director of Research should be the contact for questions about the rights of subjects)
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.
- Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
The following conditions should govern the consent process:
- Prospective subjects should be free to consider whether to participate (i.e., they should not be rushed, excessive payments should not be offered, nor should other undue influence or coercion be exerted).
- The informed consent document should be written in language understandable to the subjects.
- Documents should be written in simple language on an 8th grade reading level.
- No scientific terms should be used but if necessary than these terms should be defined.
- If the subjects are non-English-speaking, the document should be translated.
- If participants are very young minors, obtaining verbal consent after reading a short script may be best.
- Participants should be given a copy of the consent form as a reminder of the information conveyed. For online studies, participants should be instructed to print or save a copy of the form.
- Consent forms must be retained for at least three years following the conclusion of a research project.
- When the informed consent document has IRB approval, the form will be stamped approved with approval and expiration dates. This stamped document is the official one that should be given to participants, signed, and returned to the investigator for safekeeping.
Guidance on Alteration or Waiver of Consent
Please contact the Director of Research Compliance if you have any questions regarding informed consent.